G Ital Cardiol. 1989 Jan;19(1):71-80.
Ibopamine is a dopaminergic and adrenergic receptor agonist, which is active in the treatment of congestive heart failure. Since the long-term prognosis for patients with congestive heart failure remains very poor and the incidence of arrhythmic death is high, every new drug to be employed against this disease should be thoroughly tested in order to rule out any possible arrhythmogenic action. This multicentre study was designed to evaluate the effect of ibopamine versus placebo in double-blind conditions on heart rate, rhythm and electrical safety. Ibopamine was employed at a dose of 100 mg t.i.d. in 97 patients (aged 31-83 years) belonging to NYHA class II and III with congestive heart failure of different aetiology, but without any complex ventricular arrhythmias in basal conditions (couplets with R'-R" less than or equal to 400 msec, ventricular tachycardia, R on T phenomena). Using a random cross-over design the patients were submitted to 48 hr. Holter recordings in basal conditions and following 7 days of ibopamine and placebo treatment. No influence on heart rhythm was noted. No significant variations in maximum heart rate (ibopamine 117.7 +/- 20.9; placebo 118.1 +/- 20.7), medium heart rate (ibopamine 71.8 +/- 10.2; placebo 72.6 +/- 10.1) or minimum heart rate (ibopamine 55.3 +/- 11.7; placebo 54.6 +/- 10.6) were observed. The mean number/hr. of ectopic supraventricular beats was 26.1 +/- 61.9 after ibopamine and 21.7 +/- 35.8 after placebo (p = ns). The complexity of ectopic supraventricular beats did not change. The mean number/hr. of ectopic ventricular beats was 31.1 +/- 52.5 after ibopamine and 30.4 +/- 57.8 after placebo (p = ns). Neither the distribution of the patients among Lown classification nor the Final Score of the Italian Lown Classification (26.1 +/- 18.0 and 26.6 +/- 17.9 in the 1st and 2nd day of monitoring after ibopamine and 25.7 +/- 18.6 and 25.7 +/- 18.8 after placebo; p = ns) showed any difference between active treatment and placebo. Similar results were achieved when the patients were sub-divided into subgroups according to sequences of treatment (basal----ibopamine----placebo and basal----placebo----ibopamine), NYHA class II or III, aetiology of congestive heart failure (dilatative cardiomyopathy, ischemic cardiomyopathy and other aetiologies), associated treatment with digitalis or diuretics and the number and complexity of base ectopic ventricular beats. None of the patients experienced sustained ventricular tachycardia.(ABSTRACT TRUNCATED AT 400 WORDS)
异波帕明是一种多巴胺能和肾上腺素能受体激动剂，在治疗充血性心力衰竭方面具有活性。由于充血性心力衰竭患者的长期预后仍然很差，且心律失常性死亡的发生率很高，因此，每一种用于治疗这种疾病的新药都应进行全面测试，以排除任何可能的致心律失常作用。这项多中心研究旨在评估在双盲条件下，异波帕明与安慰剂相比对心率、心律和电安全性的影响。97例年龄在31 - 83岁、属于纽约心脏协会（NYHA）II级和III级、病因不同但基础状态下无任何复杂性室性心律失常（联律间期R'-R"小于或等于400毫秒、室性心动过速、R on T现象）的充血性心力衰竭患者，采用100毫克每日三次的剂量服用异波帕明。采用随机交叉设计，让患者在基础状态下以及接受7天异波帕明和安慰剂治疗后进行48小时动态心电图记录。未观察到对心律有影响。最大心率（异波帕明组117.7±20.9；安慰剂组118.1±20.7）、平均心率（异波帕明组71.8±10.2；安慰剂组72.6±10.1）或最低心率（异波帕明组55.3±11.7；安慰剂组54.6±10.6）均无显著变化。异波帕明治疗后每小时室上性异位搏动的平均数为26.1±61.9，安慰剂治疗后为21.7±35.8（p =无统计学意义）。室上性异位搏动的复杂性未改变。异波帕明治疗后每小时室性异位搏动的平均数为31.1±52.5，安慰剂治疗后为30.4±57.8（p =无统计学意义）。无论是患者在洛恩分级中的分布情况，还是意大利洛恩分级的最终评分（异波帕明治疗后第1天和第2天监测分别为26.1±18.0和26.6±17.9，安慰剂治疗后分别为25.7±18.6和25.7±18.8；p =无统计学意义），活性治疗组与安慰剂组之间均未显示出任何差异。当根据治疗顺序（基础状态→异波帕明→安慰剂和基础状态→安慰剂→异波帕明）、NYHA II级或III级、充血性心力衰竭的病因（扩张型心肌病、缺血性心肌病和其他病因）、是否联合使用洋地黄或利尿剂以及基础室性异位搏动的数量和复杂性将患者分为亚组时，也得到了类似的结果。没有患者发生持续性室性心动过速。（摘要截选至400字）
